Abstract
To prospectively evaluate the effectiveness of endovascular brachytherapy in the prevention of restenosis after femoropopliteal stent implantation in high-risk patients. Patients provided written informed consent to participate in this study, which was approved by the ethics committee. A total of 88 patients (mean age, 67.7 years +/- 10.1; 57 men [65%], 31 women [35%]) with femoropopliteal lesions (mean treatment length, 16.8 cm +/- 7.3) were included. Patients underwent percutaneous transluminal angioplasty (PTA) and stent implantation and were randomized in a double-blind fashion to undergo either gamma brachytherapy with an iridium 192 source or treatment with nonradioactive seeds. A 14-Gy dose of iridium 192 was prescribed at 2 mm into the arterial wall (target depth equals vessel radius plus 2 mm). The primary end point of the study was angiographic binary restenosis of more than 50% at 6-month follow-up. Secondary end point was either percutaneous or surgical target lesion revascularization after 6 months. Continuous data are presented as mean +/- standard deviation. Categorical data are expressed as percentages. Student t test was used to compare continuous data; chi(2) test was used to compare categorical values. Survival function was calculated with the Kaplan-Meier method. Multivariate Cox proportional hazard regression analysis was performed to enable evaluation of multivariate predictors of recurrence at 6- and 12-month follow-up. Variables included brachytherapy, clinical stage, lesion length, de novo and recurrent lesion, vessel run off, prior stenosis or occlusion, diabetes mellitus, and stent model. Revascularization and brachytherapy were accomplished successfully in all patients. The overall 6-month recurrence rate was 35% in patients who underwent only stent implantation and 33% in patients who underwent both stent implantation and brachytherapy (P = .89). Nine (10%) patients developed early reocclusion in the segment treated with a stent (two patients [4%] in the stent group and seven [17%] in the stent and brachytherapy group); of these patients, three in the stent and brachytherapy group experienced reocclusion within 24 hours of the intervention. Late (>30 days after intervention) thrombotic occlusion was observed in three patients (7%) in the stent and brachytherapy group. Brachytherapy does not improve 6-month patency after femoropopliteal stent implantation in high-risk patients because of a high incidence of early and late thrombotic occlusion.
Published Version
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